Pirsue: Product Information (Page 2 of 2)

EFFECTIVENESS

The effectiveness of pirlimycin was demonstrated in a field dose response study in lactating dairy cattle with clinical mastitis. Three investigators enrolled 486 cows from 39 herds. Cows with abnormal milk (clots, flakes) and with or without udder clinical signs (swelling, redness, or soreness) were enrolled and treated, regardless of the mastitis pathogen isolated or the pre-treatment somatic cell count. Cows were treated in the affected quarter(s) with 50, 100, or 200 mg of pirlimycin twice at a 24-hour interval. A non-treated control group was included. In this study, an individual quarter was cured if it had normal milk, no udder clinical signs, and if the milk was negative for any mastitis pathogen at 10 days post-treatment. If no bacteria were isolated pre-treatment, a decrease in somatic cell count was required. A cow was cured if all enrolled quarters in that cow were cured. All three treatment levels had significantly greater cow cure rates than the non-treated control group. Based on this study, the dose of 50 mg of pirlimycin per quarter administered twice at a 24-hour interval was determined to be the effective dose for the treatment of clinical mastitis.

ANIMAL SAFETY

Two pivotal studies addressing the safety of pirlimycin administered at dosages of 50 mg or 200 mg (4X) into all four quarters twice at a 24-hour interval indicate that the formulation is safe and non-irritating to the bovine udder. Safety observations were also made during the clinical effectiveness study. No udder irritation was noted due to intramammary infusion with pirlimycin during these studies.

An additional study was conducted to determine the safety of extended duration therapy. Twenty lactating Holstein cows, first lactation or greater, at various milk production levels, and with no evidence of clinical mastitis were enrolled and treated with pirlimycin administered at a dosage of 50 mg/quarter in all four quarters daily for eight consecutive days. Cows were monitored for general health, changes in milk production and quality, and signs of udder irritation for a total of 14 days, beginning three days prior to the first treatment. Milk production was not affected by treatment. SCCs of treated cows were statistically significantly increased post-treatment relative to the pre-treatment level. A total of 24 pirlimycin-treated quarters (32%) in 15 cows had increased SCCs (>200,000 cells/mL) for at least two consecutive milkings. Of these, six treated cows (8 quarters) had a concurrent bacterial infection attributable to a mastitis pathogen. Udder irritation occurred in seven pirlimycin-treated cows (10 quarters). Abnormal strip cup scores occurred in six pirlimycin- treated cows (9 quarters). Most of the abnormal udder and strip cup observations were seen in quarters where bacteria were also isolated.

Corroborative data from field studies and field use reports indicate that although intramammary infusion of pirlimycin hydrochloride at 50 mg/quarter administered from two to eight consecutive days was well tolerated, repeated infusion with pirlimycin increases the potential for intramammary infections and subsequent clinical mastitis due to environmental bacteria, including coliform bacteria. Adverse reactions, including clinical signs of mastitis (udder swelling and abnormal milk), increased SCCs, and death from coliform mastitis have been reported in cows following extended therapy with pirlimycin. Some, but not all, adverse reactions were associated with failure to thoroughly clean quarters and to use aseptic infusion technique.

MILK AND TISSUE RESIDUE DEPLETION

The established tolerance of pirlimycin in milk is 0.40 ppm. Milk residue depletion studies were conducted in cows with clinical mastitis. In one study, cows were infused with 50 mg of pirlimycin twice at a 24-hour interval into all quarters regardless of the number of affected quarters. In a second study, cows with a single mastitic quarter were infused with 50 mg of pirlimycin twice at a 24-hour interval into only the affected quarter. In a third study, normal cows were infused with 50 mg of pirlimycin twice at a 24-hour interval into all four quarters. As a result of these three studies, milk taken from cows during treatment and for 36 hours following treatment must not be used for food and must be discarded. For extended duration of therapy (once daily for up to 8 consecutive days), a milk residue study was conducted where cows received 50 mg of pirlimycin per quarter into all four quarters for 8 consecutive days. This study confirmed that milk taken from cows during treatment and for 36 hours following the last treatment must not be used for food and must be discarded.

The established tolerance for pirlimycin in liver (the target tissue) is 0.5 ppm. A pivotal tissue residue study was conducted following administration of 50 mg of pirlimycin twice at a 24-hour interval into all four quarters. Following receipt of the 50 mg of pirlimycin twice at a 24-hour interval into all four quarters, the liver residue decline data from this study supports a 9-day pre-slaughter withdrawal period.

For extended duration of therapy, a second tissue residue study was conducted. Each lactating cow received 50 mg pirlimycin per quarter into all four quarters, once daily for 8 consecutive days. Using the established tolerance for pirlimycin of 0.5 ppm in the liver, these data support a 21-day pre-slaughter withdrawal period for extended duration pirlimycin therapy. Extended duration of therapy is considered as any treatment period longer than 2 days (up to 8 consecutive days) of therapy.

EFFECT ON MILK MANUFACTURING STARTER CULTURES

A study was conducted to examine the effect of varying concentrations of pirlimycin in milk on the growth of bacterial starter cultures used to produce fermented milk products. Pirlimycin did not adversely affect bacterial starter cultures used for the production of fermented milk products at concentrations found following normal label use including proper milk discard periods. Violative levels of pirlimycin (>0.40 ppm) can adversely affect the growth of bacterial starter cultures.

STORAGE CONDITIONS

Store at Controlled Room Temperature 20 to 25°C (68 to 77°F). Store Plastets in Carton or Pail Until Used.

HOW SUPPLIED

PIRSUE Sterile Solution is available in unbroken packages of 12-10 mL Plastet Disposable Syringes with 12 individually wrapped 70% isopropyl alcohol pads. The Plastet Disposable Syringes are packaged in Cartons (12-10 mL Plastet Disposable Syringes per carton) and in Pails (12 packages of 12-10 mL Plastet Disposable Syringes or 144 Plastets per pail).

Approved by FDA under NADA # 141-036
zoetis
Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

Product of China
Revised: May 2019
126544I03

PRINCIPAL DISPLAY PANEL — Pirsue Carton Label

Pirsue Carton Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Pirsue Container Label

Pirsue Container Label
(click image for full-size original)
PIRSUE
pirlimycin hydrochloride injection, solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-7688
Route of Administration INTRAMAMMARY DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIRLIMYCIN HYDROCHLORIDE (PIRLIMYCIN) PIRLIMYCIN 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID 4.23 mg in 1 mL
SODIUM CITRATE 8.82 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-7688-1 12 SYRINGE in 1 CARTON contains a SYRINGE
1 10 mL in 1 SYRINGE This package is contained within the CARTON (54771-7688-1)
2 NDC:54771-7688-2 144 SYRINGE in 1 PAIL contains a SYRINGE
2 10 mL in 1 SYRINGE This package is contained within the PAIL (54771-7688-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141036 09/07/2000
Labeler — Zoetis Inc. (828851555)

Revised: 07/2020 Zoetis Inc.

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